Work Schedule Standard (Mon-Fri)

Environmental Conditions Laboratory Setting Job Description Division/Site Specific Information:

High Point, NC is a commercial manufacturing and development site focusing on gelatin based drug delivery dosage forms (softgels) . High Point is a Softgel Center of Excellence since 1996, offering extensive development and commercial scale capabilities for a variety of softgel technologies.

Location:

4125 Premier Drive, High Point, NC 27265

Discover Impactful Work:

T he QC Microbiologist-I i s r es po n si b l e f or t h e c o m p l e t e te s t i ng a nd re s u l t s d o c u m e n t a ti o n of a ny of t h e f o l l o w i n g : R a w Ma t e r i a ls , I n - P r o cess , F i n is h e d P r odu c t , S t a b i l i t y , T e c hn i c a l S er v ic e sa m p le s o r p r o je c t s w i t h i n t he Q C M i c r o b i o l o g y L a bo rat o r y , i n a m a nn e r c o n s i s t e n t w it h e s t a b l is h e d s ta n d ar d s . Day in the

Life:

T est i ng / D o c u me n t a ti o n : 80% Perform microbiological testing including identification of micro-organisms, water activity, bioburden, and growth promotion testing. Ensure all microbiological procedures reflect current practice and complies with current USP/EP requirements. Perform the routine Environmental Monitoring program on site. Co l le c t plant purified water and perform nitrate, chlorine, pH, TOC, and conductivity, and microbial testing. P re p a r e m e d ia , a nd/or us e t he commercially p re p a r e m e d ia for microbial testing , and au t o c la v e f o r w a s t e d is p o sal . Perform any microbial alert/action required from routine EM, water, microbial testing, etc. Drive a culture of continuous improvement by employing Practical Process Improvement concepts, reporting metrics, and communicating internally to diverse audiences. Perform other duties as assigned. S t and a r d i za ti o n s / P r e pa r a t o r y S e t U p: 10%

• P erf o r m daily verifications o f i n s tr u m e nts s u c h a s b a la n c es , pH m eter s, and pipettor a s r e q u ire d by wo r k i n str u c ti o n s .
• a m ong o t h e r s o l u ti o ns i n c l u d i ng m icr ob i o l o g ic a l s o l u ti o n s .
• P re p a r e m e d ia , and other microbiological solutions, us e t he A u t o c la v e f o r w a s t e d is p o sal .

Order and receive lab supplies and maintain inventory of lab supplies. H ou s e k ee p i ng: 5% C lean and or g ani z e a l l la bo rat o ry a r eas i n cl u ding b e n c h, s in k s, d r a w e r s, c ab i ne t s, sol v ent cabi n e t s, fu m e hoo d s, r e f ri g erato r s, f ree ze rs, d es i cc a t o rs, a n d s t ora g e a re a s. O cca s ion a lly c l ean lab o r a t o ry pipe t t e s and ot h er g la s s w are. Mai n t a in lab o r a tory i n s tr u m ents di s po s ing of w a s tes, c l ea n ing them, and r epl a cing consu m able p a r ts a s r equ i r e d. Maintain 5's cleaning/ visual management in the laboratory. T r a i n i n g and D e v el o p m e nt: 5%

• P ar t i c i p a t e i n on g o i ng t r ai n i ng f or t he d e v el op m e nt of s k ill s a nd res p on s i b i l i t y w i t h a n e m ph asi s on te c hno l o gy .
• A ssi s t t r a i n i ng of o t h e r a n a l y st s i n ar e a s o f e x p e r t i se .

Keys to

Success:

EDUCATION AND EXPERIENCE

B ac h e l o r ' s D e g re e from an accredited College/University i n C h e m istr y , Micr o b i o l o gy , B i o l o gy , B i o c h e m is t r y, Biotechnology, or rel a te d f ie l d. Microbiology degree strongly preferred No prior experience required in microbiology laboratory

KNOWLEDGE, SKILLS, ABILITIES

Must demonstrate a high level of commitment to delivering timelines and milestones to achieve business objective. Ability to apply GMP regulations and international guidelines to all aspects of the position. Excellent communication and listening skills Position requires knowledge of Current Good Manufacturing Practices (cGMPs) and FDA/industry regulations. Must comply with PSG Controlled Substance Policy and meet applicable DEA security clearance requirements if requested. Excellent Benefits Benefits & Total Rewards | Thermo Fisher Scientific Medical, Dental, & Vision benefits-effective Day 1 Paid Time Off & Designated Paid Holidays Retirement Savings Plan Tuition Reimbursement OTHER Relocation assistance is NOT provided Must be legally authorized to work in the United States now and in the future, without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening